Not recruiting

Study on the Accuracy of 68Ga-FAPI-46 and Fludeoxyglucose (18F) PET/CT Scans for Staging and Restaging in Patients with Ovarian Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Ovarian Cancer, a type of cancer that begins in the ovaries. The study will use two different imaging methods to help understand the disease better. The first method involves a special injection called 68Ga-FAPI-46, which is a solution used in a type of scan called PET/CT. The second method uses another injection called Fluor-18-FDG, which is also used in PET/CT scans. These scans help doctors see how the cancer is behaving inside the body.

The purpose of the study is to compare how well these two imaging methods work in detecting ovarian cancer. Participants will undergo both types of scans at different stages of their treatment. The study will look at how these scans can help in the initial diagnosis and in checking the cancer's status after treatment. This will help doctors understand if the new method, using 68Ga-FAPI-46, provides better information than the traditional method with Fluor-18-FDG.

Throughout the study, the safety of the 68Ga-FAPI-46 injection will be monitored. Participants will have their heart rate and blood pressure checked before and after the injection to ensure there are no adverse effects. The study aims to see if the new imaging method can improve how doctors manage and treat ovarian cancer, potentially leading to better outcomes for patients.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of ovarian cancer or a strong suspicion of it, based on medical data.
The assessment ensures that the patient is physically and mentally able to participate and can provide informed consent.
Step 2
First imaging session
The first imaging session involves a FDG PET/CT scan. This scan uses a solution called Fluor-18-FDG, which is injected as an intravenous solution.
The purpose of this scan is to assess the cancer's stage and to provide a baseline for comparison with future scans.
Step 3
FAPI PET/CT scan
A FAPI PET/CT scan is performed using a solution called 68Ga-FAPI-46, administered as an intravenous infusion.
This scan aims to evaluate the diagnostic accuracy of FAPI PET/CT compared to the FDG PET/CT.
Step 4
Treatment phase
During the treatment phase, patients may undergo chemotherapy as part of their standard care. This phase is not directly part of the trial but is relevant for subsequent imaging.
Step 5
Restaging imaging session
After chemotherapy, a second set of imaging sessions is conducted. This includes both FDG PET/CT and FAPI PET/CT scans.
These scans are used to restage the cancer and assess any changes in the tumor and surrounding areas.
Step 6
Data analysis and follow-up
The results from the imaging sessions are analyzed to compare the effectiveness of the FAPI PET/CT against the FDG PET/CT.
Follow-up assessments may be conducted to monitor any changes in health status and to evaluate the safety of the 68Ga-FAPI-46 injection.

Who can join the trial?

5 criteria

Must have a new diagnosis of **ovarian cancer** confirmed by a **biopsy** (a small sample of tissue taken to check for cancer) or be highly suspected to have ovarian cancer based on all information reviewed by a team of specialists in women's cancers.
Must be considered suitable for surgery, with or without prior **chemotherapy** (treatment with drugs to kill cancer cells), as determined by the team of specialists.
Must be physically and mentally able to take part in the research study.
Must be 18 years or older and able to give consent to participate in the study.
Must be able to read and understand Danish.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with Ovarian Cancer cannot participate.
Only female patients are eligible, so male patients cannot participate.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

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Verified
Aalborg University Hospital
Aalborg, Denmark

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Investigated drugs

68Ga-FAPI-46: This is a special imaging agent used in PET/CT scans to help doctors see certain types of cancer more clearly. It is injected into the body and helps highlight cancerous areas during the scan, making it easier to diagnose and understand the extent of ovarian cancer. This trial is looking at how well this imaging agent works compared to another one and how it might change the way doctors manage the treatment of ovarian cancer.

What is already known about the treatment

68Ga-FAPI-46 – This medication is administered as an injection and is used in conjunction with PET/CT scans to improve the diagnostic accuracy for staging and re-staging in patients with ovarian cancer. Currently, it is being studied in clinical trials to assess its effectiveness and safety compared to traditional FDG PET/CT scans. The main therapeutic indication is for the detection and management of ovarian cancer. At the molecular level, 68Ga-FAPI-46 targets fibroblast activation protein, which is often overexpressed in cancerous tissues, allowing for enhanced imaging of tumors. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are part of the female reproductive system. It often goes undetected until it has spread within the pelvis and abdomen. In its early stages, it may not cause noticeable symptoms, but as it progresses, symptoms can include abdominal bloating, pelvic pain, and changes in bowel habits. The disease can spread to nearby tissues and organs, and in advanced stages, it may affect distant parts of the body. The progression of ovarian cancer can vary, with some types growing slowly and others more rapidly. Understanding the specific type and stage of ovarian cancer is crucial for determining its progression.